FDA Looking into Singulair Suicide Reports

Singulair, a popular drug used to control asthma, might be linked to suicidal thoughts and behavior, the Food & Drug Administration (FDA) said today. The agency has decided to undertake a safety review of Singulair, and is advising that patients taking Singulair be monitored for behavioral changes, including suicidal thoughts and behavior.

Singulair, marketed by Merck & Co,. is one of a class of drugs called leukotriene receptor antagonists. Singulair was approved to treat asthma and the symptoms of allergic seasonal allergies and to prevent exercise-induced asthma. Side effects of Singulair include gastrointestinal disturbances, hypersensitivity reactions, sleep disorders and increased bleeding tendency. Other leukotriene modifying medications include Accolate, which is also a leukotriene receptor antagonist and Zyflo and Zyflo CR, which are leukotriene synthesis inhibitors.

Over the past year, Merck has updated the prescribing information and patient information for Singulair to include tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008) among reported post-marketing adverse events. According to the FDA, last month the agency discussed with Merck how to best communicate these labeling changes to prescribers and patients. Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and provide prescribers with patient information leaflets about Singulair. The Singulair website includes the most current prescribing information and patient information for Singulair

The FDA also said it is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide. The FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. The FDA said it is reviewing the post-marketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair. The FDA also said it is reviewing post-marketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.

The FDA said it anticipates that it may take up to 9 months to complete the ongoing Singulair safety evaluations. As soon as this review is complete, the FDA will communicate the conclusions and recommendations to the public.

The FDA still maintains that Singulair is an effective medicine for the treatment of asthma and seasonal allergies. The FDA said patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.